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A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Cross-over Phase 2 Study of Continuous 5-Hour Intravenous Infusions of BMS-986231 in Patients with Heart Failure and Impaired Systolic Function

Primary* Evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo. Secondary* Evaluate the effects of BMS-986231 on the left ventricular (LV)…

A 6-part first-in-human study of LOU064 consisting of a 4 part randomized, double-blind, placebo-controlled SAD and MAD study to investigate the safety and tolerability in healthy volunteers, subjects with atopic diathesis and subjects with atopic dermatitis, an open-label food effect study and a double-blind formulation effect study in healthy volunteers

To explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LOU064 over a treatment period of 4 weeks in a cohort of subjects with atopic dermatitis.

A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.

Primary Objective: To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack in subjects with NMO/NMOSD.Secondary Objectives:1. To compare the efficacy of MEDI-551 versus placebo on the reduction of EDSS…

Study to clinically evaluate the QT/QTc interval prolongation potential of vericiguat in patients with stable coronary artery disease in a 2-arm, placebo-controlled, randomized, double-blind, double-dummy design including a vericiguat multiple-dose part with fixed up-titration periods and moxifloxacin as positive control (for assay sensitivity testing, nested into the placebo treatment)

The objective of this study is to evaluate the effect of multiple doses of vericiguat on the QTcinterval in patients with stable CAD10 within the exposure range observed in Phase II/IIIstudies:Primary objective:* To investigate whether there is a…

Randomized, double blind, placebo- and active comparator- controlled 3-way crossover study in healthy subjects to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ENX-201

To assess PK of MPhs and MP.

A Phase 2a Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel Group, Dose-Range Finding Study of MVT-602 in Healthy Premenopausal Women Undergoing Controlled Ovarian Stimulation (COS) Using a Minimal Stimulation Protocol.

To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women undergoing COS to…

Immunisation, Treatment and Controlled Human Hookworm Infection

Primary objective:* To determine the protective efficacy of repeated short term exposure to hookworm infection Secondary objectives:1. To explore the immunological response after repeated hookworm infections2. To evaluate the safety of and number of…

Multiple dose escalation study in a multicenter, randomized, single-blind, parallel-group,
placebo-controlled design to investigate safety, tolerability, pharmacokinetics, and
pharmacodynamics of BAY 1213790 administered subcutaneously in healthy male subjects.

The purpose of this study is to investigate how safe the new compound BAY 1213790 is and how well it is tolerated when it is administered as an injection under the skin to healthy male volunteers. BAY 1213790 has been administered to humans before.…

Effect of the SGLT-2 inhibitor dapagliflozine on impaired awareness of hypoglycemia in type 1 diabetes

Primary objective: to investigate the effect of treatment with the SGLT-2 inhibitor dapagliflozin on the awareness of and counterregulatory hormone responses to hypoglycemia in people with type 1 diabetes and impaired awareness of hypoglycemia.…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Palovarotene in Subjects with Multiple Osteochondromas

Primary Objective• To evaluate the efficacy of two dosage regimens of palovarotene compared with placebo in preventing new osteochondromas (OCs) in subjects with multiple osteochondromas (MO) due to exostosin 1 (Ext1) or exostosin 2 (Ext2) mutations…

A Randomized, Controlled, Double-blind Continuation Study Comparing the Long*term Safety and Efficacy of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Subjects with Lupus Nephritis

Primary Objective* To assess the long-term safety and tolerability of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN. Secondary Objectives* To assess the…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn*s Disease (CARMEN CD 305)

Coprimary: The coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn*s disease (CD) in:* Inducing clinical remission based on 2 item patient reported outcome (PRO) (abdominal pain…

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAR443060 in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Double-blinded part:The primary objectives of the study are as follows:• To investigate the safety and tolerability of 28 days of oral doses of SAR443060 in subjects with ALS.The secondary objectives of the study are as follows: • To characterize…

A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy.

This study has been transitioned to CTIS with ID 2022-502832-37-00 check the CTIS register for the current data. To assess efficacy and safety of ivosidenib/enasidenib vs. placebo in combination with induction therapy and consolidation therapy…

Efficacy and safety of bumetanide oral liquid formulation in children and adolescents aged from 7 to less than 18 years old with Autism Spectrum Disorder.
A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop.

The primary objective is to demonstrate the superiority of bumetanide (0.5mg BID) oral liquid formulation compared to placebo in the improvement of ASD core symptoms after 6 months of treatment in ASD children and adolescents aged from 7 to less…

High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS)

* Primary Objective: To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in subjects with non ST elevation acute coronary syndrome (NSTE ACS) who are taking maximally tolerated statin therapy.* Secondary Objective(s): To evaluate the…

Proton pump inhibition for secondary hemochromatosis in hereditary anemia, a phase III placebo controlled randomized cross-over clinical trial.

Primary Objective to show that PPIs compared to placebo are an effective treatment of secondary hemochromatosis in a relative large number of patients with hereditary anemia and mild iron overload. Secondary Objectives: To assess the safety and side…

A randomized, double-blind, double-dummy, placebo-controlled, three-way crossover study to investigate the effects of mexiletine and lacosamide on nerve excitability and evoked pain tests in healthy subjects.

Primary Objective- To evaluate the feasibility and test-retest variability of nerve excitability threshold tracking - To investigate the sensitivity of nerve excitability measures to detect the effects of mexiletine- To investigate the sensitivity…

A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Primary Objective:* To evaluate the effect of EDP-305 on alkaline phosphatase (ALP) levels.Secondary Objective:* To evaluate the safety and tolerability of EDP-305* To evaluate the effect of EDP-305 on bilirubin levels* To evaluate the effects of…

A phase 2, randomized, vehicle and ketoconazole-controlled, evaluator-blinded, study to explore the efficacy, pharmacodynamics and safety of omiganan 1.75% topical gel BID in patients with mild to moderate facial seborrheic dermatitis.

Primary Objective* To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis Secondary Objectives* To explore skin and faecal microbiome in patients with seborrheic dermatitis * To evaluate the…